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October 12, 2014

Guest Post: Myriad -- A Direct and Unexceptional Approach

Is there a chain of reasoning that leads to the outcome in Myriad more shortly and directly than that outlined by Justice Thomas and without invoking judicial exceptions? It is strongly arguable that this is indeed the case and that, applying Occam's razor, the shorter chain of reasoning is to be preferred.

Doubts about the Myriad reasoning become apparent on studying a book by Justice Antonin Scalia and Bryan Gardner, Reading Law, the Interpretation of Legal Texts, Thompson/West, 2012. A reader hoping to find a chapter explaining judicial exceptions will come away disappointed: they are not indexed and there is no specific discussion of them. The Omitted-Case Canon at pp. 93-109 represents the closest approach, but begins with a quote from Justice Frankfurter: "Whatever temptations the statesmanship of policymaking might wisely suggest, construction must eschew interpolation and evisceration. [The judge] must not read in by way of creation." The expected result of applying an unwise law as written, leading to a serious defect, is that the legislature will cure it. "The statute books will become more complete, and improvised judge-made exceptions that cannot be found in the text of enacted laws will become less numerous." A theme of the book is that non-textual interpretation of the Constitution, statutes and other legal documents such as contracts should be avoided because judicial over-reaching is autocratic rather than democratic.

The above doubts become reinforced on re-reading the introduction to the opinion of Chief Justice Berger in Chakrabarty which is in agreement with Scalia and Gardner:

In cases of statutory construction we begin, of course, with the language of the statute. Southeastern Community College v. Davis, 442 U.S. 397, 405 (1979). And "unless otherwise defined, words will be interpreted as taking their ordinary, contemporary, common meaning." Perrin v. United States, 444 U.S. 37, 42 (1979). We have also cautioned that courts "should not read into the patent laws limitations and conditions which the legislature has not expressed." United States v. Dubilier Condenser Corp., 289 U.S. 178, 199 (1933).

It will be recalled that the questions before the Court were firstly whether a naturally occurring segment of deoxyribonucleic acid (DNA) is patent eligible under 35 U.S C. § 101 by virtue of its isolation from the rest of the human genome and secondly whether synthetically created DNA known as complementary DNA (cDNA), which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins, is eligible.

Following Justice Scalia, the Court's first task was to interpret 35 U.S.C. § 101 and determine whether the questions before the Court could be resolved using the express wording of the statute: only if that task was impossible was it necessary to reach the judicial exceptions.

One basis by which a naturally occurring segment could qualify under § 101 is if it could be regarded as a new and useful composition of matter. A definition of that term was adopted by Chief Justice Berger in Chakrabarty:

"[C]omposition of matter" has been construed consistent with its common usage to include "all compositions of two or more substances and . . . all composite articles, whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids." Shell Development Co. v. Watson, 149 F. Supp. 279, 280 (DC 1957) (citing 1 A. Deller, Walker on Patents 14, p. 55 (1st ed. 1937)).

However, an isolated naturally-occurring DNA segment does not fall within the above definition because it is a single substance and not a mixture of substances and because it is not the result of chemical union (i.e., synthesis by the hand of man) but instead is merely an otherwise unchanged fragment of a larger naturally-occurring molecule. Insofar as Myriad treated the claims in issue as composition claims it arguably gave the statutory language a meaning broader than its plain meaning and conflicted with Chakrabarty and Shell Development.

The alternative and more plausible basis on which the isolated naturally-occurring DNA segment could have been eligible under § 101 is as a new and useful manufacture. Again in Chakrabarty a definition is provided:

[T]his Court has read the term "manufacture" in 101 in accordance with its dictionary definition to mean "the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery." American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 11 (1931).

The standard set out in American Fruit Growers was that there must be a transformation: a new and different article must emerge having a distinctive name, character, or use, as explained in Hartranft. In order to qualify as a new manufacture relevant new utility for the isolated naturally-occurring segment had to be demonstrated. As explained in the dissenting opinion of Judge Bryson in the Federal Circuit the analysis should be from the standpoint of a geneticist rather than a chemist, and the isolated wild-type BRCA1 gene had no relevant new utility for the following reasons:

The structural differences between the claimed "isolated" genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form. The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession. In order to sequence an isolated gene, each gene must function in the same manner in the laboratory as it does in the human body. Indeed, that identity of function in the isolated gene is the key to its value. The naturally occurring genetic material thus has not been altered in a way that would matter under the standard set forth in Chakrabarty. For that reason, the isolation of the naturally occurring genetic material does not make the claims to the isolated BRCA genes patent-eligible.

It follows that the claimed isolated naturally-occurring DNA segment was not covered by § 101 either as a composition of matter or as a manufacture, and that invoking judicial exceptions to reach that result was unnecessary.

The status of the cDNA was equally easy to resolve using the express language of the statute. It differed from the naturally-occurring segment insofar as that it comprised the exons of the naturally occurring sequence joined directly one-to another and without intervening introns. It was a new chemical substance resulting from a chemical union brought about by the hand of man, and as such was plainly an eligible composition of matter.

Do these points matter, insofar as a decision has already been handed down and no different outcome is suggested? It is suggested that they do because they emphasize the wide and relevant applicability of the language of the statute, and provide a basis for reconsideration of the appropriate balance between the express provisions of the statute and less-certain judge-made exceptions. It is possible that straightforward interpretation of the statutory language concerning new and useful processes and machines and avoidance of unnecessary reliance on judicial exceptions could simplify and illuminate the discussion of computer and business-method inventions as in Alice.

* Mr. Cole is a European Patent Attorney and Partner with Lucas & Co. in Warlingham, Surrey, UK and Visiting Professor at Bournemouth University.

Comments

"The structural differences between the claimed "isolated" genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form. The use to which the genetic material can be put, i.e., determining its sequence in a clinical setting, is not a new use; it is only a consequence of possession."

So then, from the point of view of the geneticist, or anyone else, just what was holding us back from the new and profoundly useful genetic testing for breast cancer before we "possessed" the gene?

Not yet read the article, but the words of the title immediately bring the notion that your advice that follows will not be heeded by the Supreme Court - the Court will not allow THEIR (implicit) writing to be turned into dead letters - no matter what the actual words of Congress are. See Prometheus.

Nice article. (BTW, it's Chief Justice BURGER, not Berger.) You're citation to what former Chief Justice Burger said in Chakrabarty confirms what I've suspected: the courts (including the Royal Nine) are not to read in language which is otherwise missing from the explicit statute. These so-called "implicit" exceptions (that's how the Royal Nine characterize them) are not in the 35 USC 101. Accordingly, the holdings in Mayo, Myriad, and Alice Corp., in violating the principle of not reading in language that isn't expressly in statute, are built on a "foundation of sand" that is based on (unprincipled) judicial fiat, not principled reasoning.

Findings of fact are completely inconsequential. Legal holdings, however, are critical because they govern subsequent cases.

In Myriad Justice Bryson held that there was no new utility for full-length BRCA1, and his opinion was affirmed on appeal by Justice Jackson. That is a fact finding, and there is from a legal standpoint no point whatsoever in discussing whether or not it is correct. The next case will have a different trial record on which different fact findings may be made. The fact findings in one case have no binding effect on the next case, as any first year law student should be aware.

However, the rule of law is important. In the case of Myriad the holding was that a naturally occurring genetic sequence was not patent-eligible merely because it was isolated. That holding is critical and merits detailed analysis which it has in the main received only inadequately and superficially up to now, see my earlier guest post on this topic:

The purpose of this posting is to show that the same result can be reached more simply and straightforwardly by considering the express wording of the statute.

Despite the fact that it is of no legal significance whatsoever other than as between the parties, natural personal curiosity has in the past persuaded me to look into the question whether the Supreme Court was right to hold that full-length BRCA1 is valueless. The patent does not report its actual isolation, and Myriad had only found some 27,000 of the 81,000 base pairs in the gene. They had disclosed no protocol for obtaining the full length gene as a discrete isolated molecule. To the best of what I have been able to ascertain, no mutational analysis is based on full-length BRCA1, only on fragments containing the various individual exons, and the full-length gene has no practical utility whatsoever. If that is wrong, I am more than glad to hear the details, but that is the best I have been able to glean from the disclosure of the patent and from web searches directed to the practical analyses conducted by Myriad and others. So I entirely agree with you that the Myriad patent disclosed useful information, but that was not reflected in what was argued before the Supreme Court.

Under the test proposed by the author, would a synthesized DNA molecule having the same sequence as the DNA molecule in Myriad meet the "composition of matter" test? Such a synthesized DNA molecule would be assembled from multiple substances, nucleotides, that would be transformed into the DNA molecule. And even the nucleotides can be synthesized from other molecules.

Conversely, wouldn't many polymers fail the "composition of matter" test, because they are only formed from one "substance", i.e., a monomer?